The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to \< 18 years) with HIV.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
Capsules administered once daily according to dosing recommendations per product monograph
Tablets administered once daily according to dosing recommendations per product monograph
Tablets administered orally once daily with food
Pediatric Infectious Disease Associates
Long Beach, California, United States
Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, TAF, and TFV
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). AUCtau for ATV (Cohorts 1 Part A, 2, 3, and 4 \[Groups 2 to 4\]); DRV (Cohorts 1 Part A, 2, and 3); TAF (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 \[Groups 1 to 3\] taking F/TAF); and TFV (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 \[Groups 1 to 3\] taking F/TAF) will be reported.
Time frame: Predose on Day 1, and postdose up to Week 48
Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) Through Week 24
Time frame: First dose date up to Week 24 plus 30 days (Cumulative data through Week 24)
Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities Through Week 24
Time frame: First dose date up to Week 24 plus 30 days (Cumulative data through Week 24)
PK Parameter: Ctau of ATV, DRV, COBI, FTC and TFV
Ctau is defined as the observed drug concentration at the end of the dosing interval. Ctau for ATV (cohorts 1, 2, 3, and 4 (Groups 2 to 4)), DRV (cohorts 1, 2, and 3), COBI (except Cohort 5), FTC and TFV (cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF) will be reported.
Time frame: Predose on Day 1, and postdose up to Week 48
PK Parameter: Cmax of ATV, DRV, COBI, TAF, FTC and TFV
Cmax is defined as the maximum observed concentration of drug. Cmax for ATV (Cohorts 1, 2, 3, and 4 \[Groups 2 to 4\]) and DRV (Cohorts 1, 2, and 3); for COBI (except Cohort 5); for TAF, FTC and TFV (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF) will be reported.
Time frame: Predose on Day 1, and postdose up to Week 48
PK Parameter: CL/F of ATV, DRV, COBI, TAF, FTC and TFV
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Background Regimen (BR) include Food and Drug Administration (FDA)-approved nucleos(t)ide reverse transcriptase inhibitors (NRTIs) including zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), and emtricitabine (FTC).
Tablets administered orally once daily
Solution administered orally
ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites.
Tablets for oral suspension
Tablets for oral suspension
Peter Morton Medical Building
Los Angeles, California, United States
University of Colorado Denver
Aurora, Colorado, United States
The George Washington University
Washington D.C., District of Columbia, United States
University of South Florida
Tampa, Florida, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
University of Texas Health Science Center of Houston
Houston, Texas, United States
Hospital General de Agudos Cosme Argerich
Buenos Aires, Argentina
Helios Salud
Buenos Aires, Argentina
University of the Free State
Bloemfontein, South Africa
...and 13 more locations
CL/F is defined as the apparent oral clearance following administration of the drug. CL/F for ATV (Cohorts 1, 2, 3, and 4 \[Groups 2 to 4\]) and DRV (Cohorts 1, 2, and 3); for COBI (except Cohort 5); for TAF, FTC and TFV (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF) will be reported.
Time frame: Predose on Day 1, and postdose up to Week 48
PK Parameter: Vz/F of COBI, TAF, FTC and TFV
Vz/F is defined as the apparent volume of distribution of the drug. Vz/F for COBI (Except Cohort 5); for TAF (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF); for FTC and TFV (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF) will be reported.
Time frame: Predose on Day 1, and postdose up to Week 48
PK Parameter: AUCtau of COBI and FTC
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). AUCtau for COBI (Except Cohort 5) and FTC will be reported.
Time frame: Predose on Day 1, and postdose up to Week 48
PK Parameter: AUClast of TAF, FTC and TFV
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. AUClast for TAF (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF); for FTC and TFV (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF) will be reported.
Time frame: Predose on Day 1, and postdose up to Week 48
PK Parameter: Clast of TAF
Clast is defined as the the last observed quantifiable concentration of the drug in plasma. Clast for TAF (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF) will be reported.
Time frame: Predose on Day 1, and postdose up to Week 48
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose date up to Week 48 plus 30 days (Cumulative data through Week 48)
Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
Time frame: First dose date up to Week 48 plus 30 days (Cumulative data through Week 48)
Percentage of Participants with HIV-1 RNA < 50 Copies/mL at Week 24 and as Defined by the US FDA-defined Snapshot Algorithm
Time frame: Week 24
Percentage of Participants with HIV-1 RNA < 50 Copies/mL at Week 48 and as Defined by the US FDA-defined Snapshot Algorithm
Time frame: Week 48
Change from Baseline in CD4+ Cell Counts (cells/μL) at Week 24
Time frame: Baseline, Week 24
Change from Baseline in CD4+ Cell Counts (cells/μL) at Week 48
Time frame: Baseline, Week 48
Change from Baseline in Percentage of CD4+ Cells at Week 24
Time frame: Baseline, Week 24
Change from Baseline in Percentage of CD4+ Cells at Week 48
Time frame: Baseline, Week 48
Acceptability of COBI and F/TAF as Measured by Palatability Score
Time frame: Week 48